Safety and Efficacy of Catheter Ablation for Atrial Fibrillation in Patients with Percutaneous Atrial Septal Closure Device

Authors, Journal, Affiliations, Type, DOI

• Authors: Jalaj Garg, Kuldeep Shah, Mohit K. Turagam, Pragna Janagam, Andrea Natale, Dhanunjaya Lakkireddy, on behalf of the Electrophysiology Collaborative Consortium for Meta-analysis (ELECTRAM) Investigators
• Journal: J Cardiovasc Electrophysiol 2020;31(9):2328–34. Received 27 April 2020, accepted 21 May 2020
• Affiliations: Medical College of Wisconsin (lead); West Virginia University; Icahn School of Medicine at Mount Sinai; East Tennessee State University; Texas Cardiac Arrhythmia Institute at St David's Medical Center; Kansas City Heart Rhythm Institute
• Type: Systematic review and meta-analysis of single-arm studies, reported to PRISMA; Newcastle–Ottawa tool used for quality appraisal; random-effects models with Cochran's Q and I² for heterogeneity. No conflict-of-interest declarations
• DOI: 10.1111/jce.14616

Overview

Patients with a percutaneous atrial septal defect (ASD) occluder who develop AF present a specific technical problem: transseptal puncture for left atrial access must be made through, or around, an implanted device, and the perceived risk of device dislodgement has historically pushed electrophysiologists toward long-term antiarrhythmic drugs instead. This meta-analysis pooled the only three published series — 64 patients in total, all from high-volume centres — and found that puncture succeeded in 100%, freedom from AF was 77.7% (95% CI 65.7–86.3) over 6–22 months, and no device was dislodged and no residual interatrial shunt developed. Puncture through the device took significantly longer than through native septum (237.3 versus 180 minutes total procedure time, P=0.004), and recurrence did not differ between approaches. The price of the technique as reported is a 4.7% rate of inadvertent epicardial (aortic root) puncture, which the authors flag as high even for expert operators. The evidence base is three uncontrolled single-centre series, which is the main reason this page rates the paper medium rather than high.

Keywords

atrial fibrillation ablation; atrial septal device closure; transseptal puncture

Key Takeaways

The clinical problem

• AF is the commonest arrhythmia in clinical practice, including in patients with ASD and after surgical or percutaneous closure.
• Access to the left atrium by transseptal puncture is the critical step in AF ablation.
• With a prior percutaneous ASD or patent foramen ovale occluder, puncture may be difficult because of an oversized device or altered septal anatomy, with limited or no visualisation of the interatrial septum.
• Increased technical difficulty and the perceived risk of device dislodgement cause some operators to defer ablation and continue antiarrhythmic drugs — exposing patients to long-term drug toxicity.

Why AF matters in this population

• ASD is the second most common congenital heart disease, with a good prognosis in the absence of haemodynamic overload.
• 15–20% of patients over 40 years with haemodynamically significant ASD develop atrial arrhythmias; mechanisms include long-standing atrial stretch with an inflammatory response, volume overload, the deployed device acting as an anatomical barrier promoting re-entry, and age-related structural change.
• ASD closure — surgical or percutaneous, particularly after age 40 — does not prevent atrial arrhythmia, and nearly 50% of patients undergoing percutaneous closure are at increased risk of later AF; the risk exceeds that of the general population.
• Because AF begets AF and progressive atrial remodelling worsens the substrate, aggressive treatment in this group is argued for rather than optional.

Search and included studies

• 191 citations identified; 179 excluded as duplicates, reviews or case reports; three studies met criteria (N = 64 patients), published follow-up 6–22 months.
• Included series: Santangeli et al. (n=39), Li et al. (n=9), Sang et al. (n=16).
• Devices: Amplatzer (43/64), Cardioseal (20/64), Lifetech (1/64).
• Median time from closure to ablation ranged 11–46 months across studies (ranges 6–82 months).

Patient characteristics

• Mean age 54.2 ± 8.8 years; 68.75% men (n=44).
• Mean left atrial diameter 45.2 ± 4.1 mm; mean LVEF 54.5 ± 4.9%.
• 81.25% (n=52) had AF before percutaneous ASD closure; 18.75% (n=12) developed it after.
• AF type: paroxysmal 50% (n=32), persistent 39.1% (n=25), long-standing persistent 10.9% (n=7).

Procedural results

• Transseptal puncture succeeded in 100%.
• All but one patient underwent puncture under fluoroscopic plus intracardiac echocardiographic (ICE) guidance.
• Route: native septum 81.25% (n=52), through the closure device 18.75% (n=12).
• Access: single puncture 29.7% (n=19), double puncture 70.3% (n=45); 4 of the 45 double punctures were via the device.
• Acute procedural success (elimination of all pulmonary vein potentials and non-pulmonary vein triggers) 98.4% (n=63); mitral isthmus block was not achieved in one patient.
• All patients had pulmonary vein isolation; additional lesions varied by study and operator preference (coronary sinus, left atrial appendage, interatrial septum, superior vena cava, mitral isthmus, cavotricuspid isthmus, roof line).

• Freedom from AF 77.7% (95% CI 65.7–86.3), I² = 0% — comparable to ablation outcomes in patients without a closure device, though the authors make that comparison against published series rather than a matched control group.
• No significant heterogeneity in any pooled estimate.

Complications

• Three inadvertent epicardial punctures (4.7%), with no short- or long-term sequelae: two proceeded immediately to puncture via the closure device after pericardial effusion was excluded, and one was aborted and reattempted via the device two days later.
• One groin haematoma.
• No pericardial effusion, stroke, pulmonary vein stenosis or device dislodgement, and no residual interatrial shunt or device deformation on contrast echocardiography (with Valsalva) at immediate, 1, 3 and 6 months.

Why there is no residual shunt

• The concern with puncturing through the device was creation of a persistent iatrogenic ASD.
• Animal work shows closure devices are covered with protein and cellular deposition within about 3 months, and the devices are resilient elastic polymer mesh with shape memory — the authors' proposed explanation for spontaneous sealing.
• The authors concede that device shadowing may limit detection of a small residual shunt, so absence on contrast echo is not the same as proven absence.

Timing and extension to other left-sided procedures

• On pooled observation — no definite conclusion — puncture via native septum or via the device appears safe at least 6 months after implantation.
• The authors extend the implication to other left-sided procedures requiring transseptal access: premature ventricular contraction ablation, ventricular tachycardia ablation and left atrial appendage closure.

Limitations of the document

Authors' own stated limitations

• All three included studies were single-arm, non-randomised, prospective and subject to confounding.
• All came from high-volume, experienced centres, so results cannot be generalised to low-volume or less experienced operators — a caution the authors attach specifically to the 4.7% epicardial puncture rate.
• Limited data mean the findings cannot be generalised to all commercially available or investigational occluder devices.
• Ablation practice varied substantially between studies; all did pulmonary vein isolation, but additional ablation was at operator discretion because there is no consensus strategy in persistent AF.

Additional limitations evident in the design

• 64 patients across three series is a case series with arithmetic, not a comparative evidence base. There is no control group of patients with an ASD device treated medically or ablated by a different approach, so the 77.7% freedom from AF has no internal comparator — it can only be set against historical figures from a different population.
• The device-versus-septum comparison is observational within series, and the numbers are very small: 12 punctures through the device, with recurrence data available for a subset. A risk ratio of 1.18 with a confidence interval of 0.35–4.00 excludes nothing.
• The 4.7% epicardial puncture rate is the paper's most clinically important number and is under-analysed. All three events occurred in high-volume centres; the paper does not report which route was being attempted, how many attempts preceded the puncture, or whether imaging modified practice afterwards.
• Publication and reporting limits — abstracts and case reports were excluded, which for a rare scenario will have removed exactly the cases that carry the complications; no funnel-plot asymmetry assessment is reported despite the stated intent.
• No data on arrhythmia monitoring intensity, so freedom from AF across studies may be measured with different stringency.
• Follow-up is short (6–22 months) for a population with a progressive atrial substrate and a device in the septum; late shunt or late device erosion would not be captured.
• Guideline status. This is a 2020 pooled analysis of small series; nothing in it constitutes a recommendation, and the appropriate use is to reassure that the procedure is feasible in experienced hands, not to define its safety margin.

Key Concepts Mentioned

• concepts/Catheter-Ablation-AF — the procedure and its general indications
• concepts/Atrial-Septal-Defect — the underlying congenital lesion, its arrhythmia burden and the PVI-before-closure strategy
• Transseptal puncture; fossa ovalis; intracardiac echocardiography; fluoroscopic guidance
• Device dislodgement and cardiac erosion as procedure-specific hazards
• Residual interatrial shunt and its detection by contrast echocardiography with Valsalva
• Pulmonary vein isolation with or without non-pulmonary vein trigger ablation

Key Entities Mentioned

• concepts/Atrial-Septal-Defect
• entities/Atrial-Fibrillation
• Amplatzer, Cardioseal and Lifetech septal occluders
• ELECTRAM Investigators — the collaborative consortium
• Santangeli, Li and Sang — the three included series

Wiki Pages Updated

• Created: wiki/sources/af-ablation-asd-device-jce-2020.md
• Updated: wiki/concepts/Catheter-Ablation-AF.md
• Updated: wiki/concepts/Atrial-Septal-Defect.md
• Updated: wiki/sourceindex.md